International Regulatory Considerations
Vietnam is one of the new Asian tigers. With a population of about 86 million, it is the third-largest country by population in Southeast Asia and the 13th largest in the world. According to the International Monetary Fund, from 2000 to 2008, its economy grew at an average annual rate of about 7.5%—one of the highest rates in Asia. Vietnam is currently attracting a great deal of foreign investment, especially from foreign manufacturers that are relocating due to rising wages in coastal and southern China. Read more...
It may sound intimidating, but if foreign companies are willing to do the legwork, there are many good reasons to consider launching a medical device plant in India. Few statistics on the country’s device market are available but, with the help of our medical partner who has been in business in India for more than 10 years, we estimate the market to be about $2 billion, growing at 15% per year. The market’s growth has been driven by an increase in both government and private sector expenditures in healthcare, increased coverage of medical insurance, and rising incomes. Read more...
Japan’s consumption of medical devices makes it an attractive market for global medical device manufacturers. But manufacturers hoping to sell their devices in Japan must pay careful attention to the revised Pharmaceutical Affairs Law (PAL). It aligns Japan’s regulatory requirements more closely with those of other advanced nations. In this article, we examine the changes, challenges, and benefits of the revised PAL. Read more...
